GIAZO- balsalazide disodium tablet, film coated
Salix Pharmaceuticals, Inc
1 INDICATIONS AND USAGE
GIAZO is indicated for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older.
Limitations of Use:
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Effectiveness of GIAZO in the treatment of female patients was not demonstrated in clinical trials [see Clinical Trials (14.1)].
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Safety and effectiveness of GIAZO therapy beyond 8 weeks have not been established.
2 DOSAGE AND ADMINISTRATION
The dose is three 1.1 g GIAZO tablets to be taken 2 times a day with or without food (6.6 g per day) for up to 8 weeks.
3 DOSAGE FORMS AND STRENGTHS
GIAZO is available as yellow, oval, film-coated tablets containing 1.1 g balsalazide disodium, with BZT debossed on one side of the tablet.
4 CONTRAINDICATIONS
GIAZO is contraindicated in patients with hypersensitivity to salicylates, aminosalicylates or their metabolites, or to any of the components of GIAZO tablets [see Description (11)].
5 WARNINGS AND PRECAUTIONS
5.1 Exacerbations of Ulcerative Colitis
Balsalazide is converted to mesalamine, which has been associated with an acute intolerance syndrome that may be difficult to distinguish from an exacerbation of ulcerative colitis. In controlled clinical trials with GIAZO in adults with ulcerative colitis, 7% of male patients reported exacerbation of the symptoms of ulcerative colitis. Symptoms include cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache, and rash. Observe patients closely for worsening of these symptoms while on treatment. If acute intolerance syndrome is suspected, promptly discontinue treatment with GIAZO.
5.2 Renal Impairment
Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis and renal failure, has been reported in patients given products that release mesalamine in the gastrointestinal tract. Evaluate renal function prior to initiation of GIAZO therapy and periodically while on therapy. Exercise caution when using GIAZO in patients with known renal dysfunction or a history of renal disease.
5.3 Use in Hepatic Impairment
There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine. Because balsalazide is converted to mesalamine, use caution and consider liver function testing when administering GIAZO to patients with liver disease.
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure of GIAZO in 565 ulcerative colitis patients with mildly to moderately active disease. GIAZO was evaluated in one placebo-controlled trial (168 treated with GIAZO), one active-controlled trial (210 treated with GIAZO); and a subset of these patients also participated in an uncontrolled, open-label, extension study (additional 187 treated with GIAZO). The population studied had a mean age of 43.1 (range: 18-80) years; approximately 94% of patients were < 65 years old, 49% were male, and 84% were white.
In the placebo-controlled trial, the most common adverse reactions with GIAZO in male patients were headache, nasopharyngitis, anemia, diarrhea, fatigue, pharyngolaryngeal pain, and urinary tract infection. 10% of patients in the GIAZO group and 13% of patients in the placebo group discontinued treatment due to an adverse reaction. The majority of adverse reactions were mild to moderate in severity. The most common serious adverse reactions in both the placebo and GIAZO groups were gastrointestinal disorders, which were mainly associated with symptoms of ulcerative colitis.
Adverse reactions occurring in at least 2% of male patients and at a rate numerically higher than placebo in the placebo-controlled trial are listed in Table 1.